On January 31, 2024, the United States Food and Drug Administration (FDA) issued a final rule, amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation - under 21 CFR 820, to align more closely with the International Organization of Standardization (ISO) standard for Quality Management Systems for medical devices that are used by many other regulatory authorities around the world.
The Quality Management System Rule (QMSR) rule emphasizes risk management activities and risk-based decision making and aims to reduce regulatory burdens on device manufacturers and importers by harmonizing domestic and international requirements, specifically through the adoption of ISO 13485.
As staged by the FDA, 21 CFR Part 820 covers “the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use,” including the facilities and designs used for those processes.
By aligning key aspects of a medical device manufacturer's quality management system (QMS) with the international standard, they hope to simplify compliance requirements across multiple regulatory authorities.
Device manufacturers and importers will have until February 2, 2026 to comply with the new rule, while maintaining the option to adhere to current QS regulations until the deadline.
As you navigate through the process of compliance with the new ruling in 2026, RQMIS has a team of expert Quality Consultants who can help you with all of your QMS needs. We can cover the whole spectrum, from providing templates you can use to create your own custom system, to designing an entire quality system for your company from the beginning.
We can also provide a full range of auditing services for your QMS, including complete management of the internal audit program. We also offer comprehensive training courses to train your internal staff, so that they can perform future audits for your organization.
Audit Services
- Supplier Audits
- Internal Audits
- Compliance Audits
- Internal Auditor Training